现场警报报告提交SOP

FieldAlertReport(FAR)–GuidanceforSubmissionStandardOperatingProcedure(SOP)andGuidelinetodescribetheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.标准操作程序（SOP）和指南，用于描述将在美国分销/销售产品的现场警报报告（FAR）提交给美国食品和药物管理局（FDA）的过程和要求。SOPforFieldAlertReportSubmission现场警报报告提交SOP1.0 OBJECTIVE/目的ThisSOP/GuidelinedescribestheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.本SOP/指南描述了向美国食品和药物管理局（FDA）提交现场警报报告（FAR）的流程和要求，用于在美国分销/销售的产品。2.0 SCOPE/范围ThisSOP/Guidelineappliestothereportingrequirements,asoutlinedin21CFR314.81(b)(1)(i)(ii)NDAFieldAlertReport(FAR).

本SOP/指南适用于21CFR314.81(b)(1)(i)(ii)NDA现场警报报告(FAR)中概述的报告要求。ThisSOP/GuidelinedescribestheprocesstosubmitthecurrentFormFDA3331andanyothersubsequentcommunicationstotheFDAfordrugproductsdistributedtotheU.S.market.本SOP/指南描述了提交当前FDA3331表格的过程以及向FDA提交的任何其他后续通信，用于在美国市场分销的产品。FieldAlertReport(FAR)shallbefiledifaqualityeventimpactstheidentity,safety,purity,andqualityoftheproduct,asdetailedin21CFR314.81(b)(1)(i)(ii).如果质量事件影响产品的特性、安全性、纯度和质量，则应提交现场警报报告（FAR），详见21CFR314.81(b)(1)(i)(ii)。FieldAlertReport(FAR)arerequiredtobesubmittedtotheUSFDA,forbothconfirmedorunconfirmedproblemsmeetingthedefinitionoftheregulationasdetailedbelow:现场警报报告(FAR)必须提交给美国FDA，对于符合法规定义的确认或未确认问题，详述如下：Informationconcerninganyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle.有关导致药品或其标签被误认为或应用于另一物品的任何事件的信息。Informationconcerninganybacteriologicalcontamination,oranysignificantchemical,physicalorotherchangeordeteriorationinthedistributeddrugproductoranyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationestablishedforitintheapplication.有关任何细菌污染，或分销药品中任何显着的化学、物理或其他变化或变质，或药品的一个或多个分销批次不符合申请中为其建立的规范的信息。ThisprocedureappliestodistributedNDAandANDAofProducts(includingthosemanufacturedatathird-partycontractmanufacturingsite)aswellasthoseproductsmarketedintheUnitedStates.此程序适用于已分发的NDA和ANDA产品（包括在第三方合同制造地点制造的产品）以及在美国。CompliancewiththisSOP/Guidelineismandatory,andthisSOP/Guidelineisapplicablegloballytoallcompany’sproductsmarketedtotheUSmarket.遵守本SOP/指南是强制性的，并且本SOP/指南在全球范围内适用于所有公司向美国市场销售的产品。EXCLUSIONS/排除:Research&Development(R&D)activitiesareexcludedfromthescopeofthisSOP/Guideline.研究与开发(R&D)活动不在本SOP/指南的范围之内。TherequirementsforreportingBiologicalDeviationReports(BDPR)totheFDAareexcludedfromthescopeofthisSOP/Guideline.向FDA报告生物偏差报告（BDPR）的要求不在本SOP/指南的范围内。RESPONSIBILITY–SUBMISSIONOFFIELDALERTREPORT:责任——提交现场警报报告：QualityAssuranceHeadshallberesponsiblefor:质量保证负责人应负责：Notifyingthe–Quality-AmericasoftheQualityeventwithinthe1stworkingday(Day-1)forevaluation/determinationofFieldAlertReport(FAR)applicability.在第一个工作日（第1天）将质量事件通知美国质量负责人，以评估/确定现场报警报告（FAR）的适用性。NotifyingHead-CorporateQualityCompliance(CQC)incasetheCAPAinitiatedforFieldAlertReport(FAR)investigationsmayhaveanyglobalimpact.通知公司质量合规(CQC)负责人，以防现场警报报告（FAR）调查发起的CAPA可能具有任何全球影响。Initiatingaformalinvestigation,byelectronicmeans(inTrackwiseoranequivalentsystem)orwherethemanualsystemisfollowed,

bythe3rdworkingday(Day-3)forRegulatoryHead–UStosubmittheinitialFieldAlertReport(FAR)totheFDA.通过电子方式（Trackwise或等效系统）或者遵循手动系统启动正式调查，由美国法规负责人在第三个工作日（第3天）提交初始现场警报报告（FAR）给FDA。Implementingimmediateactionssuchasblockingaffectedbatches,makingarrangementfortheperformanceofspotchecks,立即采取行动，例如阻止受影响的批次，安排执行抽查，ImplementinganyadditionalcontrolsrequiredinthewarehouseincaseswhereOOStestresultsorcomplaintinvestigationsmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct.在OOS测试结果或投诉调查可能影响产品的特性、安全性、纯度、强度和质量的情况下，实施仓库所需的任何额外控制。IssuingQualityAlertsinatimelymannerforanycomplaint,investigation,orOOStestresultsthatmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct,asdetailedin21CFR314.81(b)(1)(i)(ii).针对可能影响产品特性、安全性、纯度、强度和质量的任何投诉、调查或OOS测试结果及时发布质量警报，详见21CFR314.81(b)(1)(i)和(ii)。Investigating,testing,andresolvingQualityrelatedevents,andfortheevaluationandassessmentoftheimpactoftheseonotherbatchesand/orproducts.调查、测试和解决质量相关事件，以及评估和评估这些事件对其他批次和/或产品的影响。RegionalQualityHead–Americas/Designeeshallberesponsiblefor:美国区域质量负责人/指定人应负责：Receivingcommunicationfromthemanufacturingsites,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.接收来自制造现场的沟通，例如调查/偏差报告、稳定性结果、产品投诉等。EvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.§314.81(b)(1)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.根据21CFR§314.81(b)(1)(i)和(ii)评估和确定现场警报报告(FAR)适用性，适用于本标准的任何适用/保证事件。CommunicatingtheFieldAlertReport(FAR)submissiondecisiontakentotheHeadQualityandCompliance,RegulatoryHead,ManufacturingHead,andtheManagingDirector.将现场警报报告(FAR)提交决定传达给质量和合规负责人、法规负责人、生产负责人和总经理。GuidingthemanufacturingsiteandQualityteamstomeetHealthAuthorityexpectations.指导生产现场和质量团队满足卫生当局的期望。HeadofQualityandCompliance/HeadOfManufacturing/RegulatoryHead/ManagingDirector(OrRespective

Designees)shallberesponsibleFor:质量与合规负责人/制造负责人/法规负责人/总经理（或各自指定人员）应负责：ReviewingFieldAlertReport(FAR)inconjunctionwithotherrelevantstakeholders,requestingclarification,asneeded,andmakingrecommendationstoaddresstheissue.与其他相关利益相关者一起审查现场警报报告(FAR)，根据需要要求澄清，并提出解决问题的建议。ProvidingfeedbacktotheRegionalHeadofQuality–AmericasintheeventofanydisagreementwithRegionalHeads’decisiononFieldAlertReport(FAR).向美国区域质量负责人提供反馈，如果对区域负责人关于现场警报报告（FAR）的决定有任何异议。RecommendingSubjectMatterExperts(SMEs)tothesites.向现场推荐主题专家(SME)。Evaluatingthemulti-siteimpactoftheCAPAs,ifany,andmonitoringandtrackingtheprogressofthesame.评估CAPA的多站点影响（如果有），并监控和跟踪其进展。EnsuringthatproperhealthauthoritiesarenotifiedwithintherequiredtimeframeofareportableincidentrelatedtoaQualityAlertandthatinformationisavailabletoQualityAssurance,Drug/DeviceSafetySurveillance,andRegulatoryAffairs.确保在要求的时间范围内将与质量警报相关的可报告事件通知适当的卫生当局，并且该信息可用于质量保证、药物/器械安全监督和法规事务。Distribution/WarehouseHeadorDesigneeshallberesponsiblefor:分销/仓库负责人或指定人员应负责：Placementofaffectedbatchesinaquarantineholdstatusuntiltheinvestigationiscompletedandadispositionhasbeenappliedtothequarantinedbatch.将受影响批次置于隔离保留状态，直到调查完成并对隔离批次进行处置。RegulatoryAffairsHead–Us/Designeeshallberesponsiblefor:美国法规事务负责人/指定人员应负责：EvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.§314.81(b)(1)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.按照本标准，根据21CFR§314.81(b)(1)(i)和(ii)评估和确定现场警报报告（FAR）对任何适用/保证事件的适用性。Receivingcommunicationfromthemanufacturingsites,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.接收来自制造现场的沟通，例如调查/偏差报告、稳定性结果、产品投诉等。FilingaFieldAlertReport(FAR)withtheappropriateFDAdivisionandprovidinganysubsequentupdatesreceivedfromthemanufacturingsitestotheFDAAgencyfortheproduct(s)/batch(s)thathavebeendistributedtotheU.S.market.向相应的FDA部门提交现场警报报告(FAR)，并将从制造地点收到的任何后续更新提供给FDA机构，用于已分销至美国市场的产品/批次。MaintainingFieldAlertReport(FAR)logforeachFARsubmittedtotheAgency.为提交给机构的每个FAR维护现场警报报告（FAR）日志。DrugSafety/Pharmacovigilance(PVG)/MedicalAffairsHeadorDesigneeshallberesponsibleFor:药物安全/药物警戒(PVG)/医疗事务负责人或指定人员应负责：Notificationofanymarketcomplaintthatmayimpactthe通知可能影响以下方面的任何市场投诉Identity,特性Safety,安全Purity,纯度Strength,andqualityoftheproduct产品的规格和质量withinthe1stworkingday(Day-1)totheQualityHead-Americasand/orRegulatoryHead–USforevaluation/determinationofFieldAlertReport(FAR)applicability.在第一个工作日内（第1天）给美国质量负责人和/或法规负责人，以评估/确定现场警示报告（FAR）的适用性。PerformingHealthHazardEvaluation(HHE)assessmentifthequalityeventislife-threatening(deathhasorcouldoccur),permanentimpairmentofbodyfunctionorpermanentdamagerequiresmedicalorsurgicalintervention,temporaryorreversible(withoutmedicalintervention)oranyadversehealthconsequences.如果质量事件危及生命（已经或可能发生死亡）、身体功能的永久性损害或永久性损害需要医疗或手术干预、临时或可逆的（无需医疗干预）或任何不利的健康后果，则进行健康危害评估（HHE）。4.0 ABBREVIATIONSANDDEFINITIONS:缩写和定义：ANDA–AbbreviatedNewDrugApplication/简化新药申请:AnapplicationforaU.S.genericdrugapprovalforanexistinglicensedmedicationorapproveddrug.申请现有许可药方或批准药品的美国仿制药批准。API–ActivePharmaceuticalIngredient/活性药物成分:Anysubstanceormixtureofsubstancesintendedtobeusedinthemanufactureofadrug(medicinal)productandthat,旨在用于制造药物（医药）产品的任何物质或物质混合物，并且，Whenusedintheproductionofadrug,becomesanactiveingredientofthedrugproduct.当用于药物生产时，成为药物产品的活性成分。Suchsubstancesareintendedtofurnishpharmacologicalactivityorotherdirecteffectsinthediagnosis,cure,mitigation,treatment,orpreventionofdiseaseortoaffectthestructureorfunctionofthebody.此类物质旨在在疾病的诊断、治愈、缓解、治疗或预防中提供药理活性或其他直接作用，或影响身体的结构或功能。Assignable(Root)Cause/可分配（根本）原因:Theoriginorsourceofaqualityeventthathasbeenidentifiedtocausethedefect.已确定导致缺陷的质量事件的起因或来源。Themostbasicreason,whichifeliminated,wouldpreventarecurrence.最基本的原因，如果消除，将防止再次发生。ConfirmedEvent/确认事件:Dataorresultsgeneratedoutsideofthepre-establishedexpectedrangeoracceptancecriteriathatareinagreementwiththeoriginalresult.在预先建立的预期范围或验收标准之外生成的与原始结果一致的数据或结果。Aconfirmedeventshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.确认的事件应由现场质量部门调查、记录、审查和批准。ControlledDocument/受控文件:Acontrolleddocumentisareferencedocumentthat,throughthecourseofitslifecyclemaybereviewed,modified,anddistributedseveraltimes.受控文件是一种参考文件，在其生命周期过程中可能会被多次审查、修改和分发。FieldAlertForm/现场警报表:AreportsubmittedtotheFDAoutlinedintheCodeofFederalRegulation314,Subpart314.81,documentedonFormFDA3331.提交给FDA的报告在《联邦法规314》第314.81部分中概述，记录在FDA3331表格中。HHE–HealthHazardEvaluation/健康危害评估:Anassessmenttoestablishthepotentialriskassociatedwiththeuseofaproductassociatedwithapotentialqualityevent.一项评估，以确定与潜在质量事件相关的产品使用相关的潜在风险。Notlimitedtoconsideringthepopulationatrisk,conditionsthatmayexacerbateorattenuatetheriskofoccurrence,andthelikelihoodoftheriskoccurringinthefuture.不限于考虑面临风险的人群、可能加剧或减弱发生风险的条件以及未来发生风险的可能性。NDA–NewDrugApplication/新药申请:TheNDAapplicationisthevehiclethroughwhichdrugsponsorsformallyproposethattheFDAapproveanewpharmaceuticalforsaleandmarketingintheU.S.NDA申请是药物发明人正式提议FDA批准一种新药物在美国销售和上市的工具。Un-confirmedEvent/未确认事件:Originaldataorresultsthataregeneratedoutsideofthepre-establishedexpectedspecificationrangeoracceptancecriteria.在预先建立的预期规格范围或验收标准之外生成的原始数据或结果。Anon-confirmedqualityeventshallbeinvestigated,documented,reviewed,andapprovedbytheQualityUnit.未经确认的质量事件应由质量部门调查、记录、审查和批准。OOS-Out-of-Specification/不合格:Allresultsthatfalloutsidethepre-establishedspecificationsoracceptancecriteriaestablishedinthedrugapplication,drugmasterfiles,andofficialcompendiaorbythemanufacturer.超出在药品申请、DMF和官方药典中或制造商预先制定的质量标准或接受标准的所有结果。AnOOSshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.OOS应由现场质量部门调查、记录、审查和批准。SignificantChange/重大变更:Achangethatcouldreasonablybeexpectedtoaffectthesafetyoreffectivenessoftheproduct.可以合理预期会影响产品安全性或有效性的变更。QualityAlert/质量警报:Generaldeficiencyinsystems,practices,orprocessesforGMP-QAareasthatadverselyaffect,对GMP-QA领域产生不利影响的系统、习惯或流程的一般缺陷，Thesafetyorwell-beingofpatientsorpublichealthand/orthequality,safety,andefficacyofmedicinalproductsand/orthatrepresentsignificantviolationsofapplicablelegislationandguidelineswhichmayneedtobeinformed/escalatedtoSeniorManagementofCompanyforinformation/supportinresolution.患者或公共卫生的安全或福祉和/或医药产品的质量、安全性和有效性和/或严重违反适用法律和准则的行为，可能需要通知/上报公司高级管理层在决议时提供信息/支持。5.0 WORKFLOW–FIELDALERTREPORT:工作流程–现场警示报告：6.0 PROCESS–SUBMISSIONOFFIELDALERTREPORT:流程-现场警示报告的提交：FieldAlertReport(FAR)needstobefiledwheneverthemanufacturingsitegeneratesaqualityeventthatcomplieswiththeFARrequirements21CFR314.81(b)(1)(i)(ii).每当制造现场产生符合FAR要求21CFR314.81(b)(1)(i)(ii)的质量事件时，都需要提交现场警报报告(FAR)。ThetypesofqualityeventsrequiringFieldAlertsinclude,butarenotlimitedto:需要现场警报的质量事件类型包括但不限于：Anyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle(Adulteratedormisbranded).Examplesinclude,butarenotlimitedto:任何导致药品或其标签被误认为或应用于另一物品（掺假或贴错标签）的事件。示例包括但不限于：Labelingmix-uporerrors标签混淆或错误Incorrectbottlelabel错误的瓶子标签Incorrectinsert不正确的说明书Conflictinginformationonthelabelorinsert标签或说明书上的冲突信息Anincorrectexpirationdatethatallowsaproducttobedistributedbeyonditsintendedexpirationdate.错误的失效日期导致产品在其预期失效日期之后分发。Foreignproduct国外产品Informationconcerninganybacterialcontamination.Examplesinclude,butarenotlimitedto:有关任何细菌污染的信息。示例包括但不限于：Reportedgrosscontamination报告的总污染Visiblemoldgrowth可见的霉菌生长Anysignificantchemical,physical,orotherchangeordeteriorationinthedistributeddrugproduct.Examplesinclude,butarenotlimitedto:经销药品的任何显着的化学、物理或其他变化或变质。示例包括但不限于：Significantspotsontablets片子上的显著斑点Significantdiscolorationordecomposition明显变色或分解Crumblingoftablets药片破碎Precipitateinasolution溶液中的沉淀Hazardoussubstances,suchasglass,metal,strongforeignodor.有害物质，如玻璃、金属、强烈的异味。Anyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationsestablishedforitintheapplication.Examplesinclude,butarenotlimitedto:任何一个或多个分销批次的药品未能满足申请中为其制定的规范。示例包括但不限于：Anout-of-specificationresultgeneratedduringstabilityand/oraretainsample(reservesample)analysiswithintheproductexpirationperiod.产品有效期内稳定性和/或留样（reservesample）分析过程中产生的不合格结果。Wherebyretentionsampleexaminationresultsforanunexpireddistributedlotindicateanissuewithcontainer-closureintegrity,label/labeling,contamination,deterioration,orotherwisenotmeetingspecifications.因此，未过期分发批次的留样检查结果表明存在容器密闭完整性、标签/标签、污染、变质或其他不符合规格的问题。Customercomplaintswherepreliminaryinformationandinvestigationindicatethelikelihoodofanissuewiththebatchunrelatedtomishandlingbythecustomer.(RefertoSOPforMarketComplaints.)客户投诉，其中初步信息和调查表明批次问题的可能性与客户处理不当无关。（请参阅市场投诉SOP。）Deviations/Investigationsthatidentifyarootcauseandscopeofpotentialimpactimplicatingadistributedbatch.确定涉及分布式批次的潜在影响的根本原因和范围的偏差/调查。ProcessofReportingtheInvestigation–FieldAlertReport:报告调查的过程-现场警示报告：TheQualityHeadshallcommunicateanyconcernsthatareidentifiedforimmediateconsiderationoffilingaFieldAlertReport(FAR)basedontheexamplesprovidedabovetotheHeadofQuality–Americasand/orRegulatoryHead–USwithinthe1stworkingday(Day-1)fortheirevaluation/determinationofFieldAlertReport(FAR)applicability.(ReferAttachment-II)质量负责人应当将被标识备案现场警示报告立即考虑任何问题（FAR）基于上面提供的质量头部的例子-美洲和/或监管头-1内美日工作日（Day-1)以评估/确定现场警报报告(FAR)的适用性。（参考附件二）TheQualityHeadshallinitiateandconducttheirinvestigationfollowingtheproceduresdescribedintheSOPforInvestigations.质量负责人应按照调查SOP中描述的程序启动和进行调查。Adescriptionoftheincidentandanypreliminaryinvestigation,supportingdocumentation,rootcause,correctiveandpreventativeactions,etc.事件描述和任何初步调查、支持文件、根本原因、纠正和预防措施等。Inaddition,theQualityHeadwillalsosubmittheinvestigationreportandCAPAstoCorporateCompliance.此外，质量主管还将向公司合规部提交调查报告和CAPA。CorporateComplianceshallreviewandevaluatethemulti-siteimpactofCAPAsandtakenecessaryactionsifapplicable.公司合规部门应审查和评估CAPA的多站点影响，并在适用时采取必要措施。ActionspriortoSubmissionofFieldAlertReport:提交现场警示报告之前的行动：Additionally,CorporateComplianceshallprovidethefeedbacktotheRegulatoryHead–theUS,ifany,beforeFieldAlertReport(FAR)submissions.(RefertoSOPforHandlingofCorrectiveandPreventiveActions-CAPA).此外，公司合规部应向监管负责人提供反馈——我们，如果有，在现场警示报告(FAR)提交之前。（有关纠正和预防措施的处理，请参阅SOP-CAPA）。TheHeadofQuality-AmericasandtheRegulatoryHead–USwilldiscussandtakearisk-baseddecisiontoconcludetherecommendationforfieldalertreportingrequirement,i.e.,whethera

FieldAlertneedstobefiledunder21C.F.R.§314.81(b)(1)(i)and(ii).美洲质量主管和监管主管–美国将讨论并做出基于风险的决定，以得出对现场警示报告要求的建议，即是否需要根据21CFR§314.81(b)提交现场警报(1)(i)和(ii)。Subsequently,theRegionalHeadofQuality–AmericasshallcommunicatetheFieldAlertReport(FAR)submissiondecisiontaken(irrespectiveofwhetherFARisrecommendedornot)tothe随后，美洲地区质量负责人应将现场警示报告（FAR）提交决定（无论是否推荐FAR）传达给HeadQualityandCompliance,质量和合规负责人ManufacturingHead,生产负责人HeadRegulatoryAffairsand法规事务主管和TheManagingDirectorasearlyaspossiblewithinthe2ndworkingday(Day-2)keepingtheRegional/SiteQualityHeadintheloop.总经理在第2个工作日（第2天）内尽早让区域/现场质量负责人了解情况。ActionsafterconfirmationtoFilingofFieldAlertReport(FAR):确认提交现场警示报告(FAR)后的行动：OncenotifiedontheFieldAlertReport(FAR)submissiondecision,一旦接到现场警示报告(FAR)提交决定的通知，AllHeadsshallberesponsibleforsendingthefeedbacktotheHeadofQuality–Americaswithinthe3rdworkingday(Day-3),onlyintheeventofanydisagreementwiththeRegionalQualityHeads’FieldAlertReport(FAR)decision.所有负责人应负责向质量负责人发送反馈——美洲3内第三个工作日（第3天），仅与区域质量负责人现场警示报告（FAR）决定任何异议的情况下。TheFARssubmittedtotheFDAareclassifiedasInitial,Follow-up,orFinalreports.提交给FDA的FAR分为初始报告、跟踪报告或最终报告。RegulatoryHead–US

shallnotifytheFDAbytelephone,bymailorotherrapidcommunicationwithinthree(3)workingdaysofthecompanybecomingawareofthereportedproblemoreventthatrequiresaFieldAlertReport(FAR),asdetailedin21CFR314.81(b)(1)(i)(ii)fortheInitialFAR.美国法规负责人应在公司获悉需要现场警示报告（FAR）的报告问题或事件后3个工作日内通过电话、邮件或其他快速沟通方式通知FDA，详见21CFR314.81(b)(1)(i)(ii)用于初始FAR。TheInitialFieldAlertReport(FAR)shallincludeanassessmentofthecauseoftheeventbasedontheinformationavailableatthetime.初始现场警示报告（FAR）应包括基于当时可用信息对事件原因的评估。IftheinitialrapidcommunicationdidnotincludetransmittaloftheinformationviathecurrentversionofFormFDA3331,theRegulatoryHead–US(ordesignee)willfollowuptheinitialcommunicationinwritingviasubmissionofFDAForm3331(referAttachment–II)totheFDADistrictOffice.如果初始快速沟通不包括通过当前版本的FDA3331表格传输信息，美国法规负责人（或指定人员）将通过提交FDA3331表格（参见附件–II）以书面形式跟进初始沟通)到FDA地区办公室。CommitmentsmademustbedocumentedandtrackedtocompletionandmadeavailabletotheFDA,ifrequested.做出的承诺必须记录在案并跟踪完成，并在FDA要求时提供。Afollow-upFieldAlertReport(FAR)willbesubmittedbytheRegulatoryHead–UStotheFDAeverythirty(30)calendardaysuntiltheinvestigationiscompletedandtheFinalFARisfiled.后续现场警报报告（FAR）将由美国监管负责人每三十(30)个日历日提交给FDA，直到调查完成并提交最终FAR。Thefollow-upFARsshallidentifytheprogressmadeintheinvestigation.跟踪FAR报告应确定调查取得的进展。TheFinalFieldAlertReport(FAR)willbesubmittedbyRegulatoryHead–UStotheFDA,notmorethanfive(5)workingdaysuponreceiptoftheconcluded(finalized)investigationreportfromthemanufacturingsites.最终现场警报报告(FAR)将由美国监管负责人提交给FDA，在收到来自制造场所的最终（定稿）调查报告后的5个工作日内。Ifthereisanunforeseendelaythatisencounteredtosubmitthefinalreportwithinfive(5)workingdays,thisincidentshallalsobedocumentedintheFieldAlertFinalReport.如果在5个工作日内提交最终报告出现不可预见的延迟，该事件也应记录在现场警报最终报告中。DrugSafety/Pharmacovigilance(PVG)/MedicalAffairsmayperformaHealthHazardEvaluation(HHE)toassesstheimpactofthequalityeventregardingtheidentity,safety,purity,strength,andqualityoftheproductforpatientsafety.药物安全/药物警戒（PVG）/医疗事务部可能会执行健康危害评估（HHE），以评估质量事件对产品的特性、安全性、纯度、强度和质量对患者安全的影响。IncludetheassessmentsummaryintheFieldAlertReport(FAR)correspondencetotheFDA,assubmittedbyRegulatoryAffairs.将评估摘要包含在监管事务部提交给FDA的现场警示报告（FAR）信函中。TrackthecompletecycleofeventsintheFieldAlertReport(FAR)log(refertoattachment-III),maintainedbytheUSRegulatoryAffairs.AllFDAFiledAlertcommunicationsandlogthesubmissionsinthatlog.在美国监管事务部维护的现场警示报告（FAR）日志（参见附件III）中跟踪事件的完整周期。所有FDA提交的警报通信并在该日志中记录提交。7.0 REQUIREMENTS–SUBMISSIONOFFIELDALERTREPORT:要求——提交现场警报报告：CompletingaFieldReportForm3331/填写现场报告表3331:FARsinvolvingforeignfacilitiescanbereportedtothejurisdictionalFDAOffice,wherethefirm’sattorney,agent,orotherauthorizedofficialresidesormaintainsaplaceofbusinessintheU.S.涉及外国设施的FAR可以报告给具有管辖权的FDA办公室，那里公司的的律师、代理人或其他授权官员在美国居住或维持营业地点。TheFieldAlertReport(FAR)formcontainsanexpirationdateinthetopleft-handcorneroftheform.EnsurethecurrentFDAForm3331isutilized.现场警报报告（FAR）表格在表格的左上角包含到期日期。确保使用现行的FDA表格3331。TheFDAwebsiteforFDAformsisfoundat/FDA表格的FDA网站位于/aboutfda/reportsmanualsforms/forms/listformsalphabetically/default.htmNote:Asanoption,theU.S.FDAhaslaunchedapilotprogramtoelectronicallysubmitFARSusingFormFDA3331A(Automated)toimprovethespeedandefficiencyofreportingqualityissuesrelatingtothemanufactureofFDA-approveddrugproducts.注意：作为一种选择，美国FDA启动了一项试点计划，使用FDA3331A表格（自动）以电子方式提交FARS，以提高报告与FDA批准的药品制造相关的质量问题的速度和效率。InstructionsareprovidedonlineforuseofForm3331A.

Fordetailsseeandenter3331A.在线提供使用表格3331A的说明。有关详细信息，请访问FDA网站并输入3331A。FollowtheFieldAlertReport(FAR)instructionssuppliedinAttachmentII.按照附件II中提供的现场警报报告（FAR）说明进行操作。CompletetheelectronicFieldAlertReport(FAR)Form3331online,saveacopytoyourcomputer,andprinttwo(2)copiesoftheform.在线填写电子现场警报报告（FAR）表格3331，将副本保存到您的计算机，然后打印2份表格副本。SubmitaseparatenarrativereportwithForm3331describingtheevent,summarizingtheinvestigation,andtheHealthHazardEvaluation,includinganycorrectiveactiontakenfortheaffectedproduct.提交一份单独的叙述性报告和表格3331，描述事件、总结调查和健康危害评估，包括对受影响产品采取的任何纠正措施。FieldAlertReport(FAR)LOG/现场警报报告（FAR）日志:Thelogmaybeaboundbook,paginated,andproperlylabeledforitsintendedpurpose,oranelectronicversionofthesame,provideditismanagedasacontrolleddocument.(refertoattachment-III)日志可以是合订本、分页并根据其预期目的正确标记，或者是相同的电子版本，前提是它作为受控文件进行管理。（参考附件三）Thelogshallcontainthefollowingheadersattheminimum(butnotlimitedto):日志应至少包含以下标题（但不限于）：ProductName/Potency产品名称/规格BatchNumber批号BatchManufacturingandExpiryDate批生产日期和有效期Packstyle包装形式ANDA/NDCNo.ANDA/NDC编号ReferenceDocumentNumber参考文件编号ComplaintNumber/OOSNumber投诉编号/OOS编号ApplicationNumber申请号ManufacturingSite生产地点FieldAlertReport(FAR)Description现场警报报告(FAR)说明ReceivingDate接收日期DatenotifiedtoFDA(Initial)通知FDA的日期（初始）DateofnotificationofFollow-upreport跟踪报告通知日期FieldAlertReport(FAR)ReportType现场警报报告(FAR)报告类型Status状态RetainallFDAFieldAlertcommunicationsandsubmissionsaspertherecordretentionprocedures.根据记录保留程序保留所有FDA现场警报通信和提交。8.0 ATTACHMENTS–FIELDALERTREPORT(FAR):附件——现场警报报告：AttachmentI–ExampleTemplateofOOS/Deviation/IncidentNotificationForm附件一–OOS/偏差/事故通知表示例模板OOS/DeviationNo:OOS/偏差编号：Date:日期：Location:地点：From:

Regional/Location(Site)

HeadofQuality区域/位置（现场）质量负责人To:RegionalHeadofQuality–Americas

区域质量负责人–美洲OOS/Deviation/IncidentofthefollowingBatch(es)recommended:………………推荐以下批次的OOS/偏差/事故：S.No.编号Product产品BatchNumber批号ManufacturingDate生产日期ExpiryDate有效期至OOS/DeviationDetails:……………OOS/偏差详情：AttachmentII–NDAFDAForm3331附件二–NDAFDA表格333